DURA-PATCH MODEL DP-XXX by BRIDGER BIOMED, INC.

The provided text is a 510(k) summary for the Dura-Patch™ Dura Substitute, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed studies with acceptance criteria and performance data as might be found for novel devices or software.

Therefore, many of the requested technical details regarding acceptance criteria and study methodologies (like sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not applicable to this 510(k) submission.

Here's a breakdown based on the provided information:

1. Table of acceptance criteria and the reported device performance:

This 510(k) summary does not present formal acceptance criteria or performance metrics in the way one might expect for an AI/software device. Instead, it focuses on demonstrating substantial equivalence to an existing predicate device based on comparative technological characteristics and safety & efficacy through material biocompatibility and established clinical use of ePTFE.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (Dura-Patch™)
Material Composition	Composed of 100% ePTFE membrane.
Intended Use	Intended to be used as a replacement for dura tissue deficiencies.
Biocompatibility	Inert and biocompatible. Has passed USP Class VI, carcinogenicity studies, hemocompatibility studies, and others. Proven nonreactive to body fluids and tissues.
Physical Properties (Comparative)	Strong enough to resist tears, supple enough to provide comfort, flexible, and impermeable to CSF. Pore size of approximately 1 micron (comparable to predicate).
Established Clinical Safety	Over 4,000,000 long-term ePTFE devices implanted to date, over 25 years of clinical use with no known adverse reactions to the material.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. This 510(k) relies on a comparison to a predicate device and the long-established safety and efficacy of ePTFE as a material. There is no mention of a specific test set or clinical study conducted on the Dura-Patch™ itself in this summary. The data provenance related to ePTFE's clinical use is global (implied by "over 25 years of clinical use" and "virtually all major tissue types"), and retrospective (historical clinical data).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. No ground truth establishment by experts for a specific test set is described. The "ground truth" for this submission is the accepted safety and efficacy of ePTFE and the predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No specific test set or adjudication method is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI/software device, and no MRMC study was conducted or referenced.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" implicitly used for this submission is:

Historical clinical outcomes data / established safety profile for ePTFE: "over 4,000,000 long-term ePTFE devices implanted to date," "In over 25 years of clinical use, and exposure to virtually all major tissue types, there have been no known adverse reactions to the material."
Biocompatibility testing results: "biocompatibility assays including U.S.P. Class VI, carcinogenicity studies, hemocompatibility studies, and others."
Performance characteristics of the predicate device: The Dura-Patch™ is stated to have comparable characteristics (strong, supple, flexible, impermeable to CSF, pore size) to the predicate device, Preclude™ Dura Substitute.

8. The sample size for the training set:

Not applicable. No training set is relevant for this physical device and its 510(k) submission.

9. How the ground truth for the training set was established:

Not applicable. No training set or associated ground truth establishment process is relevant.

Summary

{0}------------------------------------------------

K980548

MAY | 3 1998

510(k) SUMMARY OF SAFETY AND EFFICACY

Bridger Biomed Dura-Patch™

Prepared by:	Bruce G. Ruefer, President
Date:	February 4, 1998
Classification Name:	Dura Substitute; 84GXQ
Common/Usual Names:	Dura Substitute
Proprietary Name:	Dura-Patch™ Dura Substitute
Establishment Reg. No.	9028940
Classification:	Class II
Performance Standards:	Not Applicable.
Substantial Equivalence:	The dura substitute manufactured by Bridger Biomed Inc.,and is substantially equivalent to the dura substitutePreclude™ Dura Substitute, manufactured and marketed byW.L. Gore & Associates.
Product Description& Intended Use:	Dura-Patch™ Dura Substitute is a 100% ePTFE membrane,which is intended to be used as a replacement for dura tissuedeficiencies.
Comparative TechnologicalCharacteristics:	Dura-Patch™ Dura Substitute is an inert and biocompatible 100% ePTFE membrane, strong enough to resist tears, supple enough to provide comfort, flexible, and is impermeable to CSF, as is the predicate device. Both devices also have a pore size of approximately 1 micron.
Safety & Efficacy:	Dura-Patch™ is composed of 100% expandedpolytetrafluoroethylene or ePTFE. ePTFE is the most inertpolymer known at this time. ePTFE has been found to pass

4 4

{1}------------------------------------------------

biocompatibility assays including U.S.P. Class VI, carcinogenicity studies, hemocompatibility studies, and others. ePTFE has been proven many times over to be nonreactive to body fluids and tissues making it a material of choice for biomaterial applications.

Usage of ePTFE as an implant material is well substantiated with over 4,000,000 long-term ePTFE devices implanted to date. In over 25 years of clinical use, and exposure to virtually all major tissue types, there have been no known adverse reactions to the material. Many configurations of ePTFE devices are marketed including; vascular grafts; soft tissue and cardiovascular patches; suture; pericardial, peritoneal and dura replacement membranes, periodontal implants and facial implant devices.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of three faces in profile, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 3 1998

Mr. Bruce G. Ruefer President Bridger Biomed, Incorporated 2430 North 7th Street, Suite 4 Bozeman, Montana 59715

Re: K980548 Trade Name: Dura-Patch Model DP-XXX Regulatory Class: II Product Code: GXQ Dated: February 10, 1998 February 12, 1998 Received:

Dear Mr. Ruefer:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜ substantially equivalent determination assumes compliance with ........... the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

{3}------------------------------------------------

Page 2 - Mr. Ruefer

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

STATEMENT OF INDICATIONS FOR USE

The Bridger Biomed Dura-Patch™ is intended for replacement or repair of the dura.

Prescription Use . (Per 21 CFR 801.109) Y

biolles

Regulation Number and Section

§ 882.5910 Dura substitute.

(a)
Identification. A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).(b)
Classification. Class II (performance standards).